Associate Scientist II, Quality Control

The Position

This role is within Quality Control (Quality Organization). An Associate Scientist II, Quality Control supports analytical testing of pharmaceutical raw materials, in-process samples, finished drug substances/drug product, and/or stability samples for new drug substances and drug products. The role also supports Environmental Monitoring sample collection, GLP Toxicology and cGMP Clinical Trial material release testing, and stability studies. Performs multiple analytical techniques and makes sound scientific decisions with guidance from management.

Reports to the QC-EM Scientist.

• Develop understanding of cGMP requirements and meet project timelines/deliverables.
• Collect Environmental Monitoring samples in a cGMP manufacturing space.
• Perform routine analytical testing using established methods/procedures.
• Execute training requirements; ensure SOP compliance and maintain up-to-date training records.
• Use/become proficient with analytical instrumentation (e.g., HPLC, GC, FT-IR, UV/Vis, KF).
• Set up instrumentation for testing with little/no supervision; plan/execute tasks with minimal supervision.
• Perform analyses timely; troubleshoot minor analytical problems and communicate issues to senior staff/management.
• Maintain accurate laboratory notebook/worksheet records; review others’ test data as applicable.
• Aid drafting technical documents (OOS/atypical investigations, deviations, CAPAs).
• Calibrate/maintain/troubleshoot analytical equipment with supervision; remain flexible with changing priorities; additional duties as assigned.

• B.S. in Microbiology, Chemistry, or related field; 1–3 years relevant lab experience.
• cGMP laboratory requirements/operations experience.
• Familiarity with analytical instrumentation, test method validation, data acquisition systems, and cGMP policies/practices.

• Environmental Monitoring and/or cleanroom experience.
• Microbiology experience.
• Ability to interpret SOPs/test methods and write/present clearly; respond to questions.
• Mathematical, reasoning, and basic computer skills (Windows, MS Office, chromatography data systems).

• Wisconsin pay range: $70,000 USD - $85,000 USD.
• Competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where the role is located.